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Medical ghostwriting: if you’re not alarmed, maybe you’re just not paying attention

I had to go have a little lie-down after I read the The New York Timesstory this week about the scandalous practice of medical ghostwriting. Here’s how Danish researcher Dr. Peter Gøtzsche describes medical ghostwriting: “Ghostwriting occurs when someone makes substantial contributions to a manuscript without attribution or disclosure. It is considered bad publication practice in the medical sciences, andsome argue it is scientific misconduct. At its extreme, medical ghostwriting involves pharmaceutical companies hiring professional writers to produce papers promoting their products- but hiding those contributions and instead naming academic physicians or scientists as the authors.“

Here’s an extreme example of extreme medical ghostwriting. The New York Times and the journal Public Library of Science Medicine have outlined recent court documents revealing that ghostwriters paid by drug giant Wyeth Pharmaceuticals played a major role in producing 26 scientific papers published in medical journals that backed the use of hormone replacement therapy in women. That supposed medical consensus benefited Wyeth directly, as sales of its HRT drugs Premarin and Prempro soared to nearly $2 billion by 2001.

Wyeth paid Design Write, a New Jersey medical communications firm, to draft these 26 papers that were then published in medical journals between 1998 and 2005. They emphasized the benefits and de-emphasized the risks of HRT to protect against conditions like aging skin, heart disease and dementia.

But in 2002, independent researchers pulled the plug three years early on the Women’s Health Initiative, a large-scale, federally funded study of HRT. They had found that the therapy actually produced an increased risk of breast cancer, heart attack, stroke and blood clots.

Wyeth now faces over 8,400 lawsuits* from women who claim that the company’s hormone replacement therapy drugs caused them serious harm. Twenty-eight of the 31 cases that had been set for trial have been settled out of court; other cases are on appeal. Wyeth claims that they have changed their policy and now require these physician and academic ‘authors’ to actually participate in the medical research. That’s the power of 8,400 lawsuits. *

Dr. Joseph Rossof Mount Sinai School of Medicine in New York, who has conducted research on ghostwriting, explained:

“It’s almost like steroids and baseball. You don’t know who was using and who wasn’t; now you don’t know which articles are tainted and which aren’t.”

In North American medicine, doctors’ links to industry are often hidden from public view. And critics justifiably argue that such relationships can taint the integrity of medical research and patient care. A truly brilliant marketing scam.

Because physicians rely on medical literature, the concern about ghostwriting is that doctors might change their clinical prescribing habits after reading certain articles, unaware they were commissioned by a drug company.

And what about the medical journals that agree to publish these ghostwritten papers? Their editors cannot possibly be ignorant of the widespread unethical practice of ghostwriting. The Public Library of Science Medicine journal ran an editorial this week with these recommendations:

Medical journal editors need to decide whether they want to roll over and just join the marketing departments of pharmaceutical companies

Authors who put their names to such papers need to consider whether doing so is more important than having medical literature that can be believed in

Politicians need to consider the harm done by an environment that incites companies into insane races for profit rather than for medical need

Companies need to consider whether the arms race they have started will in the end benefit anyone. After all, even drug company employees get sick; do they trust ghost authors?

Dr. James H. Stein, professor of cardiology at the University of Wisconsin School of Medicine, tells this story:

“Just three days ago, I got a request to be the ‘author’ of a ghostwritten article about the effectiveness of a cholesterol-lowering drug. This happens all the time.”

Dr. Stein declined to attach his name to the paper.

Thankfully, other physicians like Dr. Stein have also refused to get into bed with Big Pharma. Dr. Charlotte Thompson, of the University of California at San Diego Medical School – and a practicing physician for 50 years – adds this question:

“How can a professor in a medical school allow his or her name to be used on an article ghostwritten for a drug company? What has happened to their ethics? One professor (in the New York Times article) was quoted that it would take her too long to do the necessary research for the article. As a salaried medical school professor, I can’t imagine what she was thinking!”

Well, what the too-busy professor was thinking was likely the old axiom of academia: publish or perish.

Dr. Carl Elliott of the Centre for Bioethics at the University of Minnesota wonders:

“How long does this have to go on before it actually is stopped? One way to stop it would be if the real authors were punished in some way. But the academics who are complicit in it all never seem to be punished at all.”

Here’s a suggestion, if ethical physicians and academics are truly serious about stopping this appalling practice: let’s start by publicizing the names of all professionals who have agreed to lend their names to industry-sponsored marketing scams. Oops, I meant “scientific research”.

Here’s an example: in a controversy reported last October, a senior psychiatrist at Emory University, Dr. Charles B. Nemeroff, drew criticism for failing to disclose to his university at least $1 million in ‘consulting fees’ from drug companies.

And here’s another: the Toronto Star has revealed that psychology professor Dr. Barbara Sherwin of McGill University claimed to be the sole author of a Wyeth-funded, Design Write-created paper published in the Journal of the American Geriatric Society. According to the Star:

Which happens to be a lie, by the way. Independent (i.e. not bought and paid for by Big Pharma) randomized control studies instead have shownan increase in the risk of heart attack or death due to heart disease with HRT, and an approximate three-fold increase in the risk of blood clots. McGill University reports that it is now investigating Dr. Sherwin.

By the way, if you’re a science writer interested in making a lot more money than you’re earning right now doing legitimate writing, consider that Design Write charges $25,000 a pop to ghostwrite scientific papers.

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* NEWS UPDATE: November 5, 2009 - A Philadelphia jury has ordered Wyeth to pay a $75 million bad-conduct award (about 20 times larger than the $3.7 million in actual damages the panel awarded to Connie Barton,an Illinois woman who developed cancer after taking Wyeth’s Prempro menopause drug). Barton, a retired records clerk, took Prempro for five years before developing breast cancer in 2002. Jurors in Philadelphia concluded Prempro helped cause the illness, and the manufacturer failed to warn Barton and her doctors adequately about the drug’s risks. Wyeth has now lost five of eight trials, including the last three in a row, since HRT cases began reaching juries in 2006. New York-based Pfizer, the world’s biggest drug company, completed its $68 billion purchase of Wyeth on October 15th.

(Bloomberg): Pfizer Inc. has paid $896 million so far to resolve about 60 percent of the cases alleging its Wyeth subsidiary’s menopause drugs caused cancer in women, the drugmaker said in a securities filing.

Pfizer, the world’s largest drugmaker, has now settled about 6,000 lawsuits alleging Prempro and other hormone-replacement drugs caused breast cancer, and has set aside an additional $330 million to resolve the remaining 4,000 suits, according to a May 10, 2012 filing with the U.S. Securities and Exchange Commission. The reserve means New York-based Pfizer has now committed more than $1.2 billion to resolving claimsthat it failed to properly warn women about the menopause drugs’ health risk.

More than 6 million women took Prempro and related menopause drugs to treat symptoms including hot flashes and mood swings before a 2002 study highlighted their links to cancer. These hormone medications are still on the market.

Thank you for bringing the subject of medical ghostwriting to our attention. Most people believe that this really affects only prescription drugs – but even over the counter medicines you buy at your local pharmacy/chemist’s shop are promoted in this fashion.

I had never even heard of this topic until now. I am disgusted — but I don’t know which of the guilty parties I’m most disgusted by: the drug companies? the doctors who pretend to be the authors of this so-called “research” which is nothing more than drug sales promo material they did not write? the universities who must be aware that their senior faculty are “on the take” like this? the editors of the medical journals? Where is this going to end?

“One way to stop it would be if the real authors were punished in some way. But the academics who are complicit in it all never seem to be punished at all.”

And that is the issue. Where are the sanctions against the physicians and scientists who are conspiring with the drug companies, knowing full well that the clear intent is to make it look like they are the true authors of these published studies? Without the addition of the name of a respected academic as “author”, journal articles submitted by medical ghostwriters would never see the light of day.

It is fraud pure and simple – the universities that hire these frauds yet do nothing to stop this practices are as guilty as the rest of the lot.